The once-daily antifungal medicine Cancidas (caspofungin acetate) of Merck & Co Inc has been approved by US FDA as empirical therapy for presumed fungal infections in febrile neutropenic patients.
Approval was based on results from the largest prospective antifungal empirical therapy trial published to date in neutropenic patients with persistent fever. This study, recently published in The New England Journal of Medicine, showed that Cancidas was as effective as AmBisome for empiric therapy of presumed fungal infections in these patients, the release from Merck says.
"Invasive fungal infections are particularly life-threatening in neutropenic patients undergoing chemotherapy for malignancies such as acute myelogenous leukaemia and non-Hodgkin's lymphoma and those who undergo haematopoietic stem cell transplantation," said Issam Raad, professor of medicine, and chairman of infectious diseases, infection control, and employee health at the University of Texas M.D. Anderson Cancer Centre, Houston.
He added, "When clinical signs, such as persistent fever despite the presence of broad spectrum antibiotics, suggest the possible presence of a fungal infection in this population, it is important to intervene with an effective treatment. This indication should provide physicians with confidence in Cancidas as an effective and generally well tolerated agent for use as empirical therapy in neutropenic patients who present with persistent fever despite ongoing therapy with broad spectrum antibiotics."
Cancidas is the first in a class of antifungals called echinocandins that inhibit fungal cell wall synthesis of ß (1,3)-D-glucan, an integral component of the fungal cell wall. Cancidas is contraindicated in patients with hypersensitivity to any component of the product.
Impressive results demonstrated across all efficacy end points The multi-centre, double-blind trial showed that Cancidas (n=556) was as effective as AmBisome (amphotericin B) (n=539), a frequently used anti-fungal agent, in treating presumed fungal infections in neutropenic patients with persistent fever.
Cancidas was first approved in 2001 for the treatment of invasive aspergillosis in patients who do not respond to or cannot tolerate other antifungal treatments. Cancidas is indicated for the first-line treatment of candidemia and other Candida infections - intra-abdominal abscesses, peritonitis (infections within the lining of the abdominal cavity) and pleural space infections (infections within the lining of the lung) and is also approved for the treatment of esophageal candidiasis.